Designing Medical Devices with Cleanliness in Mind

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

Overview:

This webinar will provide valuable guidance to medical device manufacturers on design considerations for both single-use and re-usable devices. There are certain design elements that are more difficult to clean and should be avoided whenever possible. With the "right" design, both the manufacturing and cleaning processes can be simplified.

Why should you attend: Cleanliness is a hot topic in the medical device industry. The FDA expects medical device companies to validate the cleanliness of their devices. One of the best ways to achieve a clean device is by designing it with cleanliness in mind.

Areas Covered in the Session:
  • Design Requirements
  • Single-Use Design Considerations
  • Re-usable Design Considerations
  • Design Elements to Avoid/Minimize
  • Simplifying the Manufacturing Process
  • Simplifying the Cleaning Process

Who Will Benefit:
  • QA/QC Managers and Personnel
  • Validation Managers and Personnel
  • R&D and Engineering
Kierstan Andrascik has worked in the medical device industry for more than 12 years. She founded QVET Consulting in 2009 to assist medical device manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization.

Previously, she worked at Nelson Laboratories in Salt Lake City, Utah where she served as study director covering a variety of testing including new device cleaning validations, materials characterization, and package testing. In 2002, she began developing a method to quantify residual manufacturing materials on medical devices. In 2005, ASTM published a similar method as F2459. Kierstan has been actively serving on the ASTM Device Cleanliness subcommittee since 2005. She received a Certificate of Achievement from ASTM in May 2007. In the June 2008 issue of Medical Design magazine, her article titled "How to tell if a device is really clean" was published. Then, in April 2011, her chapter “Cleaning Validations using Extraction Techniques” published in the 2nd edition of Handbook for Critical Cleaning. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.


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